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Tag No.: A0404
Based on observations, interviews and records reviews the hospital failed to ensure that drugs and biologicals were prepared and administered in accordance with physicians orders and hospital policy and procedures for three of four patients (Patient 1, 2, and 3) as evidenced by the failure to:
1. Verify allergies prior to medication administration, administer medications at the right time, obtain and respond to lab results, and clarify physicians orders for heparin infusion for Patient 1.
2. Administer the right dose and drug by giving Patient 2 the wrong doses of sliding scale insulin ten times and not administering five doses of inhalation treatment as ordered.
3. Administer the right dose of dilaudid to Patient 3, in addition to the failure to administer intravenous antibiotics at the right time.
These failures delayed Patient 1, 2 and 3's treatments and had the potential to exacerbate their disease states and further complicate their medical conditions.
Findings:
1. During medication pass observation on 8/26/10 between 9:00-9:45 a.m. in the Critical Care Unit, a critical care staff nurse (RN 2) administered medications.
While administering the medications, the medication administration record (MAR) warned that Patient 1's allergies had not been entered, "No allergy information, please call" 5 times. In the presence of the surveyor, RN 2 did not address Patient 1's missing allergy information. RN 2 did not ask Patient 1 regarding his allergy history.
During interview on 8/26/10 at 10:00 a.m., when asked about Patient 1's missing allergies, RN 2 said she had verified Patient 1 did not have any allergies earlier. RN 2 said nurses could not add allergies in patient's electronic record and that pharmacy was responsible for entering the allergy information.
During interview, on 8/26/10 at 11:00 a.m., the director of pharmacy (DOP) said the process for entering allergies into patient's electronic record was for the nurses to gather and enter the allergy information into the computer system and then for pharmacy to verify the allergy information.
Patient 1's record review on 8/26/10 at 9:50 a.m. in the company of the Assistant Vice President of quality (Admin 1), RN 2, the CCU manager (RN 4), and the Director Of Pharmacy, showed the hospital had admitted Patient 1 on 8/25/10 for complaints of chest pain and to rule out a myocardial infarction (heart attack). Patient 1 was 21 years old and had no significant past medical history.
Patient 1 had physician orders dated 8/25/10 at 9:25 p.m. for NPO (nothing by mouth) after midnight, in preparation for cardiac studies on 8/26/10. RN 2 said Patient 1 had not had been to the procedure yet. When asked regarding whether the NPO orders included oral medications, RN 2 stated a nurse in training had clarified the NPO orders earlier with the physician who wanted Patient 1 to receive his oral medications but the nurse in training had not documented the order clarification yet. The hospital could not provide a policy regarding whether NPO orders included oral medications.
Further review of Patient 1's record showed physicians orders dated 8/26/10 at 3:45 a.m. for potassium chloride 40 meq by mouth once, first dose now. Potassium chloride is used to treat low potassium levels. Low potassium levels may cause life threatening arrhythmias (heart beat irregularities) and exacerbate the condition of patients with disease. The surveyor observed the potassium administration during medication pass between 9-9:45 a.m. The EMAR showed that the potassium had been administered on 8/26/10 at 9:41 a.m. Patient 1's medical record did not contain any additional orders for potassium chloride. According to laboratory results dated 8/26/10 at 12:46 a.m., Patient 1's potassium level was 3.1 (normal levels 3.6-5.1). RN 2 could not provide an explanation for the more than five hour delay in Patient 1's potassium chloride administration. Admin 1 and RN 8 said that "now" orders should be administered within 120 minutes. The hospital failed to follow its policy regarding the five rights of medication administration, to administer medications at the right time.
During the same interview, the Director Of Pharmacy (DOP) stated the pharmacy had entered the one time potassium order and made it available on the MAR for the nurse to chart on 8/26/10 between 5:00 and 7:00 a.m. The DOP added the potassium chloride was available in the unit's automated dispensing cabinet and did not require pharmacy delivery. The DOP explained the order expired at 7:00 a.m. and at the nurse's request, pharmacy reactivated the order so that it could be administered on 8/26/10 between 8:00 a.m. and 12:00 p.m. The hospital failed to follow its policy regarding the five rights of medication administration, to administer medications at the right time.
Review of the hospital's policy and procedures regarding medication administration, "Medication Administration System" (17-21A/adopted in 6/09) on 8/26/10 at approximately 5:30 p.m., indicated that "NOW" medications must be administered within 60-120 minutes of the writing of the physician's orders. And routine medication orders will be administered within 4 hours of the physician's orders being written.
The record review, showed Patient 1 had orders, dated 8/25/10 at 9:25 p.m., for intravenous heparin (a blood thinner) per protocol over night, please hold heparin at 08:00.
On 8/25/10 at 11:42 p.m., the heparin protocol was started and Patient 1 received a bolus dose (4500 units) and was started on the intravenous heparin at 900 units per hour. Heparin is a blood thinner, used to prevent blood clots. According to the protocol, Patient 1 would require a blood draw to determine the APTT (Partial prothrombin time: a coagulation test that measures the blood's clotting ability) 6 hours after the start of the heparin infusion. The APTT is used to adjust the heparin dose. Patient 1's APTT level was due on 8/26/10 at 6:00 a.m. Patient 1's labs were collected on 8/26/10 at 6:36 a.m. and the results were available at 7:07 a.m. RN 2 stated the nurses had placed an order for a lab draw on 8/25/10 at 1:42 a.m., for a lab draw on 8/26/10 at 6 a.m. During interview, on 8/26/10 at 10:54 a.m., the lab director stated labs should be drawn within 15 minutes of the ordered time.
Patient 1's APTT was subtherapeutic at 30. According to the heparin protocol, an APTT less than 35 would require a bolus heparin dose and an increase in the intravenous heparin infusion rate. Patient 1's record did not show that he had received the additional bolus or that the heparin infusion rate was increased. RN 2 said the nurses were in report at the time of the lab results became available and the heparin drip was to be discontinued at 8:00 a.m. and so the dose adjustment was not done. RN 2 did not contact the physician to clarify the heparin orders. RN 4 stated that Patient 1's physician should have been contacted to clarify the orders and whether to administer the heparin bolus and increase the rate in response to the low APTT or to discontinue the intravenous heparin without dose adjustments as scheduled.
2. Patient 2's record review was conducted on 8/26/10 at 4:30 p.m., in the company of Admin 1, the Director Of Pharmacy (DOP), the medical oncology charge nurse (RN 7), and the unit supervisor (RN 8) showed the hospital had admitted Patient 2 on 8/8/10 for respiratory failure and altered mental status after a fall. Patient 2's medical history included chronic obstructive pulmonary disease and diabetes.
Patient 2 had physicians orders dated 8/9/10 at 4:20 a.m. for Insulin Sensitive Sliding (a sensitive scale that has less aggressive dosing than a regular sliding scale insulin) Scale Novolog Insulin (Novolog is a type of insulin). On 8/11/10 at 10:59 a.m., the physician changed the orders to Sliding Scale Insulin Regular. On 8/11/10 at 7:26 p.m., a nurse clarified the orders with the physician via telephone as follows, Finger Stick Blood Sugars, before meals and at bed time, Regular Insulin Sliding Scale with Novolog Insulin. The orders were signed by the physician on 8/12/10 at 1:05 p.m. Review of Patient 2's blood sugars and Novolog insulin administration record showed Patient 2 received 10 wrong doses of sliding scale insulin as follows:
8/11/10 8:38 p.m., blood sugar 126, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/13/10 5:34 p.m., blood sugar 122, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/13/10 8:49 p.m., blood sugar 133, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/14/10 12:01 p.m., blood sugar 121, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/15/10 9:18 p.m., blood sugar 138, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/16/10 4:43 p.m., blood sugar 146, 1 unit of Novolog Insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/16/10 8:35 p.m., blood sugar 123, I unit of Novolog insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/18/10 9:16 p.m., blood sugar 126, I unit of Novolog insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/19/10 8:57 p.m., blood sugar 126, 1 unit of Novolog insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 2 units of Novolog insulin.
8/25/10 4:30 p.m., blood sugar 162, 2 units of Novolog insulin. This is consistent with the Insulin Sensitive Sliding Scale. According to the orders for regular sliding scale insulin, Patient 2 should have received 3 units of Novolog insulin.
During interview on 8/26/10 at 5:15 p.m., RN 7 and RN 8 said that subcutaneous insulin administration required two nurses' signatures to ensure the correct insulin and dose. RN 7 explained the second nurse check is based on the information in the mediation administration record (MAR), not the original physicians order. RN 7 said the MAR showed Patient 2 was on the Insulin Sensitive Sliding Scale and not the Insulin Regular Sliding Scale as ordered. RN 7 said the nurses only review the original physicians orders when acknowledging new orders on the MAR. During the same interview, the DOP stated the pharmacist who approved the ordered on 8/11/10 entered the Sensitive Sliding Scale Novolog Insulin rather than Regular Sliding Scale Novolog Insulin.
The hospital failed to follow its policy regarding the five rights of medication administration, to administer the right medication.
Review of the hospital's policy and procedures regarding medication administration titled "Medication Administration System" (17-21A/adopted in 6/09) on 8/26/10 at 5:30 p.m., indicated the following regarding sliding scale coverage insulin, "Prior to administration of insulin dose, it must be checked by another licensed nurse. Dose must be documented on MAR by both nurses." The policy further indicated regarding MAR Procedure, "The licensed nurse shall verify the accuracy of the transcription of orders by acknowledging each entry on the MAR and the pink copy of the order.'
Review of the hospital's policy and procedures titled, "Noting Physician's Orders and 12-hour Chart Checks and Use of Rotary Dials on Medical Records" (13-11A/adopted 8/3/09) on 8/26/10 at 5:30 p.m., indicated the following, "The licensed nurse checks all orders in the computer including acknowledging medication orders on the MAR. After all orders have been verified/acknowledged, they are to be "noted" off by the licensed nurse ..."
Further review of Patient 2's medical record showed Patient 2 had orders for Advair inhaler (a corticosteroid containing inhaler). Advair is used for the maintenance treatment of chronic obstructive pulmonary disease. The original order date was 8/11/10 for 1 puff twice daily. Record review on 8/26/10 at 12:30 p.m. with RN 7 and DOP showed the Advair inhaler had stopped showing on the MAR as of the 8/21/10 evening dose. Patient 2's record did not include any orders to discontinue Advair. DOP and the medical oncology unit pharmacist (Pharm 3) said the order had dropped off the MAR due to the hospital's automatic stop order process. Patient 2 did not receive five doses of inhalation Advair starting 8/21/10 evening dose through the 8/23/10 evening dose. Pharm 3 and RN 7 said that this was a medication error because the physician did not renew the orders on time. Admin 1, RN 7, and RN 8 explained the hospital did not have a method for the nurses to compare the current MAR with the next day's MAR to verify orders did not drop off. RN 7 said that due to the electronic MAR process, there was no method for the nurse to verify all orders that had not been discontinued or changed were carried forward to the next day's MAR. DOP said occasionally orders drop off the MAR or pharmacy accidentally discontinues orders. The hospital failed to follow its policy regarding the five rights of medication administration, to administer the right medication.
3. Patient 3's clinical record was reviewed and interviews were conducted on 8/26/10 at 2:00 p.m., in the company of Admin 1, Director Of Pharmacy (DOP), and RN 7, showed the hospital had admitted Patient 3 on 8/23/10. Patient 3 presented to the emergency room on 8/3/10 with complaints of pain and bronchitis in addition to other complaints.
Review of Patient 3's emergency department physician record, showed physicians orders written on 8/23/10 at 12:50 p.m., which included dilaudid for pain and zithromax, an antibiotic.
Dilaudid 0.25mg intravenously was ordered on 8/23/10 at 12:50 p.m. Review of the MAR for 8/23/10, showed Patient 3 had received dilaudid 1mg at 2:00 p.m. and not 0.25mg, as ordered. DOP stated according to the automated dispensing device, the emergency room nurse who had administered Patient 3's mediations had removed a 2mg dilaudid syringe and wasted 1mg. The automated dispensing device showed another nurse had witnessed that 1mg of dilaudid was wasted.
The nurse who had administered Patient 3's dilaudid in the emergency room was not at work on 8/26/10 during the survey. During interview on 8/26/10 at approximately 5:30 p.m., Admin 1 stated the emergency room director had interviewed the emergency room nurse via telephone, who stated she thought she had administered the correct dose but forgot to change the quantity administered in the MAR. Admin 1 also said, that the emergency room director interviewed the nurse who witnessed the wasted dilaudid 1mg, who stated that he could not recall if the wasted amount of dilaudid was 1mg or greater. The hospital failed to follow its policy regarding the five rights of medication administration, to administer the right dose.
Zithromax 500mg (an antibiotic) intravenously was ordered on 8/23/10 at 12:50 p.m. and administered at 4:00 p.m., according to the emergency department physcian documentation record. The hospital administered Patient 3's antibiotic, more than three hours after it was ordered. Review of the hospital's policy and procedures regarding medication administration, "Medication Administration System" (17-21A/adopted in 6/09), on 8/26/10 at 5:30 p.m., indicated unless ordered stat or now, all medications will be administered within four hours of receiving the order unless previously taken prior to admission, with the exception of antibiotics, which must be administered within two hours. Admin 1 and DOP were not aware of the hospital's policy requiring antibiotics to be administered within 2 hours of the order. The hospital failed to follow its policy regarding the five rights of medication administration, to administer medications at the right time.
Tag No.: A0490
Based on observations, review of documents (clinical records and policies) and staff interviews, the hospital failed to ensure that pharmaceutical services met the needs for four of four patients (Patients 1, 2, 3, and 4) to provide safe and effective use and distribution of drugs as evidence by:
1. The hospital failed to follow its policies, Food and Drug Administration and manufacturer instructions and Black Box Warnings to ensure that Patient 3's fentanyl patch dose was appropriate prior to administration. Patient 3's fentanyl patch dose was increased upon admission, without evaluation of supplemental opiate use. Patient 3 was 88 years old, with multiple medical problems which included fluid in the lungs, which made it difficult to breath. The hospital failed to follow manufacturer's instructions regarding the use of fentanyl patches in elderly patients, who have an increased risk of respiratory depression. (Cross Reference A 500)
2. The hospital failed to ensure its fentanyl patch policy and procedures applied to all hospital patients. Patient 4, a distinct part skilled nursing facility patients, received a fentanyl patch without meeting the hospital's policy and procedures and manufacturer's criteria for opiate tolerance. (Cross Reference A 492)
3. The hospital failed to ensure the hospital pharmacist had overall responsibility for developing, supervising and coordinating activities of the hospital wide pharmacy services, as evidenced by, the lack of hospital pharmacy oversight for pharmaceutical services for the long term care patients residing at the hospital's distinct part skilled nursing facility (A492)
4. The hospital failed to develop and implement policies and procedures to ensure approved emergency medications and supplies were used and managed appropriately in accordance with standards of care and state laws. (Cross Reference A 500)
5. The hospital failed to follow its policies to ensure that one patient (Patient 1) had allergy information prior to making medications available for patient use and that the medication regimen was free from duplicate therapy. (Cross Reference A 500)
6. The hospital failed to follow its policies to ensure three patients received the right medication, the right dose at the right time, as ordered:
a. Patient 1: "Now" potassium chloride order was not administered for 6 hours and heparin drip was not adjusted as required per heparin protocol. (Cross Reference A404)
b. Patient 3: received the wrong dose of Dilaudid, 1mg instead of 0.25 and intravenous antibiotic was administered within 3 hours instead of 2 hours, as required per hospital policy. (Cross Reference A404)
c. Patient 2: received 10 wrong doses of sliding scale insulin and did not receive 5 doses of Advair inhaler as ordered. (Cross Reference A404 and A 500)
7. The hospital failed to develop and implement policies to ensure the proper storage of medications. The hospital failed to store frozen injectable medications and antibiotic solutions according to the manufacturer's storage requirements in order to guarantee medication integrity and sterility. Thereby, the hospital potentially exposed patients with serious infections, requiring intravenous antibiotic treatment, to expired antibiotics and possibly ineffective treatment. (Cross Reference A 491)
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality pharmaceutical services in a safe environment.
Tag No.: A0491
Based on observations, staff interview and administrative record review, the hospital failed to store frozen antibiotics and medications in accordance with the manufacturer's instructions to maintain medication integrity and stability for 480 bags of Baxter's frozen premixed Zosyn Injection Solution, 20 Prostin suppositories, 26 Cervidil suppositories and 1 Zostavax vial. Additionally, the hospital failed to develop and implement written policies to ensure the proper storage of medications.
These failures had the potential to expose patients to the ineffective treatment of serious infections and other conditions due to the use of expired or deteriorated drugs.
Findings:
During medication storage inspection at the main pharmacy on 8/24/10 at 2:00 p.m., in the company of the Director of Pharmacy (DOP), the pharmacy's medication freezer contained 480 bags of Baxter's frozen premixed Zosyn Injection Solution in single dose plastic containers. Review of the manufacturer's storage instructions on the antibiotics' manufacturer labels indicated to store at -20 degrees Celsius (?C) or below. Zosyn is a potent antibiotic used to treat potentially life threatening infections. Additionally, the freezer contained the following medications, which required storage at -20?C or below:
20 Prostin suppositories, used in labor and delivery procedures.
The storage instructions on the box indicated the following, "Suppositories must be kept frozen; store in freezer not above -20?C (-4?F)."
26 Cervidil suppositories, used in labor and delivery procedures.
The storage instructions on the box indicated the following, "Suppositories must be kept frozen; store in freezer not above -20?C (-4?F)."
One Zostavax vial, a vaccine used for the prevention of shingles (herpes zoster) in patients 60 years old and older. The manufacturer's storage instructions indicated the following, "ZOSTAVAX SHOULD BE STORED FROZEN at an average temperature of -15?C (+5?F) or colder."
During interview on 8/24/10 at 12:50 p.m., the DOP explained an automated wireless system continuously recorded the freezer temperatures. He added the hospital maintained freezer temperatures between -7.5?C to -20 ?C and that the system would alert staff if temperatures were to drift outside the range. Upon checking the temperature monitoring system on the computer, the DOP stated the freezer temperatures regularly fluctuated above -20?C . Review of the computer generated freezer temperature records between 6/3/10 and 8/24/10 showed that the freezer temperature was above -20?C daily.
Review of the provided hospital policy and procedures on 8/26/10 regarding medication storage, "Storage and Expiration Dates of General Medications", last reviewed on 5/10, showed the policy had not addressed the general storage of medications at room temperature, refrigerator or freezers.
During interview on 8/26/10 at 8:45 a.m., the DOP stated the policy did not address general storage of medications. The DOP could not provide a current policy that addressed medication storage in the hospital. Additionally, during interview on 8/24/10 at 12:50 p.m., the DOP stated the hospital did not have a policy and procedure to address medications exposed to out of range storage temperatures.
According to the American Society of Health Systems Pharmacist's, 1995, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital (including medication-related devices and pharmaceutical diagnostics) for inpatient and ambulatory patients. Policies and procedures governing these functions shall be developed by the pharmacy with input from other appropriate hospital staff and committees."
According to the American Society of Health System Pharmacist's, 1980, Technical Assistance Bulletin on Hospital Drug Distribution and Control, "Drug storage is an important aspect of the total drug control system. Proper environmental controls (i.e., proper temperature, light, humidity, conditions of sanitation, ventilation, and segregation) must be maintained wherever drugs and supplies are stored in the institution ...The effectiveness of the drug control system depends on adherence to policies (broad, general statements of philosophy) and procedures (detailed guidelines for implementing policy). The importance of an up-to-date policy and procedure manual for drug control cannot be overestimated ....All pharmacy staff must be familiar with the manual; it is an important part of orientation for new staff and crucial to the pharmacy's internal communication mechanism. In addition, preparing written policies and procedures requires a thorough analysis of control operations; this review might go undone otherwise."
According to a CDPH, All Facilities Letters (AFL 09-56), issued in 12/10/09, regarding Medication Safety: Storage of Medications Requiring Refrigeration, the principles of proper medication storage include the following:
Development and implementation of policies and procedures to ensure safe storage of medications under proper conditions (e.g., temperature, humidity, protection from light and security).
Development and implementation of policies and procedures to identify, remove, and properly dispose of outdated, contaminated, recalled, or otherwise unusable drug products throughout the health care organization. Additionally, development and implementation of policies and procedures to ensure that any patients who may have received a contaminated, recalled or otherwise unusable drug product are quickly identified notified and evaluated for potential untoward outcome.
Storage equipment (e.g., refrigerators, thermometers, carts and cabinets.) are maintained in accordance with standards of practice and/or manufacturer recommendations to ensure proper functioning.
Adherence to pharmaceutical manufacturer requirements for product storage.
An alerting system to quickly identify situations where high and low refrigerator temperature limits are exceeded. (This would also be applicable to medical devices used for warming intravenous and irrigating solutions.)
All medication storage areas must be periodically inspected by qualified staff in accordance with facility policy, standards of practice and/or regulatory requirements to ensure that medications are safely and properly stored.
For refrigerators used to store vaccines, the temperature should be monitored and recorded twice a day.
Tag No.: A0492
Based on interviews and record reviews, the hospital failed to ensure the hospital pharmacist had overall responsibility for developing, supervising and coordinating activities of the hospital wide pharmacy services as evidenced by the lack of hospital pharmacy oversight for pharmaceutical services for 107 long term care patients residing at the hospital's distinct part skilled nursing facility. The inconsistent provision of pharmaceutical services throughout the hospital had the potential to increase patients' risk for medication errors and could negatively impact the patient's health.
Findings:
During survey, on 8/24/10, the hospital produced a list of patients currently on fentanyl patches. Fentanyl patches are used to treat persistent, chronic moderate to severe pain. Fentanyl patches can cause severe respiratory depression and possibly death if used inappropriately in patients who are not tolerant to opiates. Therefore, patients have to be assessed to ensure opiate tolerance and to determine the appropriate fentanyl patch dose, based on amounts of opiates use. The hospital had recently developed new policies and processes regarding the use of fentanyl patches in the hospital. The list of fentanyl patch patients provided by the hospital, did not include the patients on fentanyl patches at the hospital's distinct part skilled nurse facility.
During pharmacy tour and staff interviews on 8/24/10 between 10:00 a.m. and 12:00 p.m. in the company of the Director of Pharmacy (DOP), staff pharmacist (Pharm 2),and the vice president of professional services (Admin 2), Pharm 2 said the hospital pharmacists do not review or assess orders for long term care patients at the hospital's distinct part skilled nursing facility. Admin 2 said the hospital had contracted with ...pharmacy Services to provide pharmaceutical services at the hospital's distinct part skilled nursing facility patients. Admin 2 said the hospital pharmacy had no oversight of the pharmaceutical services provided at the hospital's distinct part skilled nursing facility.
The contracted pharmacy ...Services, was licensed as a community/retail pharmacy that provided dispensing and consultant pharmacy services to skilled nursing and long term care facilities. The DOP said the medication orders for the long term care patients at the distinct part skilled nursing facility were not entered into the hospital pharmacy's computer system which allowed for checking for drug interactions and contraindications and provided multiple clinical alerts. Based on physicians' order recapitulation review, the hospital provided a list of nine patients on fentanyl patches at the hospital's distinct part skilled nursing facility.
On 8/24/10 at 12:00 p.m., the DOP said the hospital's new fentanyl patch policies and procedures were not implemented at the hospitals distinct part skilled nursing facility.
One of the patients on the list, Patient 4 was started on a fentanyl 12 mcg/hr patch on 7/30/10. On 8/13/10, the dose was increased to fentanyl patch 25 mcg/hr. The hospital had admitted Patient 4 on 4/5/07. Patient 4 was 90 years old with multiple medical problems including paralysis, renal insufficiency, and stroke. The area vice president of quality (Admin 1) provided Patient 4's medication administration record (MAR) for June, July and August 2010. Review of the MARs showed the following regarding Patient 4's opiate pain medication usage:
June 2010, hydrocodone 7.5 mg/acetaminophen 500 mg (Lortab) by mouth three times a day,
22.5 mg of hydrocodone daily.
July 2010, hydrocodone 7.5 mg/acetaminophen 500 mg (Lortab) by mouth four times a day
(start 6/28), 30 mg of hydrocodone daily
August 2010, hydrocodone 7.5 mg/acetaminophen 500 mg (Lortab) four times a day,
30 mg of hydrocodone daily
The fentanyl patch manufacturer's package insert reviewed on 8/24/10 indicated the efficacy of fentanyl 12 mcg/hr as an initiating dose had not been determined. In addition, patients who are not opioid tolerant have experienced hypoventilation and death during the use of fentanyl patches. Therefore, fentanyl patches should be used only in patients who are opioid tolerant. The manufacturer and the Food and Drug Administration (FDA) boxed warning indicate the following, fentanyl patch is indicated for management of persistent, moderate to severe chronic pain that:
Required continuous, around-the-clock opioid administration for an extended period of time, and could not be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.
Additionally, fentanyl patches, should only be used in patients who are already receiving opioid therapy,who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.
Patient 4's hydrocodone usage at 30 mg per day is equianalgesic to 30-45 mg of oral morphine. Patient 4 did not meet the criteria for opiate tolerance as required by the manufacturer and the FDA's boxed warning.
Review of the hospital's new policy for fentanyl patches on 8/24/10, titled "Criteria for Safe and Appropriate Prescribing of Fentanyl Transdermal Patches" (62-3317/adopted 7/12/10) indicated the following:
The purpose of the policy was to assure safe and appropriate prescribing of fentanyl patches for all patients.
The use of fentanyl patches was contraindicated in patients who were not opioid tolerant.
Opioid tolerant patients are those who are already receiving opioid therapy and who require a total daily dose at least equivalent to fentanyl patch 25 mcg/hr.
Patients who are considered opioid tolerant who have been taking, for a week or longer, at least 60 mg of morphine daily or an equianalgesic dose of another opioid.
During interview on 8/26/10 at approximately 2:00 p.m., the DOP said in order for a patient to receive a 12 mcg/hr fentanyl patch, they would still have to meet the opioid tolerant definition in the policy of having been on the equivalent of 60 mg of oral morphine daily for a week or longer.
Review of the Hospital's Department of Public Health License on 8/26/10, valid through 4/4/11, the hospital was licensed for 209 General Acute Care Beds and 145 Skilled Nursing Beds (D/P SNF of the hospital)
According to a current hospital census provided on 8/24/10, the hospital had 107 patients long term care patients in the skilled nursing facility who were receiving their medications and pharmacy services from ...pharmacy services. The hospital pharmacist had no oversight of pharmaceutical services for those patients.
Review of Pharmacy Services Agreement between ...pharmacy services and the D/P SNF of the hospital dated 5/14/09 indicated ...pharmacy services would provide the hospital's long term care patients at the D/P SNF with dispensing and consultant pharmacy services.
Tag No.: A0500
Based on observations, record reviews and staff interviews, the hospital failed to ensure the safe and effective distribution and use of medications as evidenced by:
1. The lack of pharmacy and therapeutics committee approved written policies and procedures to determine the contents, use and process for maintaining emergency drugs and supplies, in accordance with state laws and standards of care.
2. The failure to evaluate and assess the appropriateness of the Fentanyl Patch dose increase upon admission for one of four patients, Patients 3, in accordance with manufacturer's instructions and the hospital's policy and procedures.
3. Incorrect order entry which resulted in one of four patients, Patient 2 receiving the wrong dose of sliding scale insulin and not receiving Advair inhalation treatment.
4. The failure to ensure that a pharmacist evaluated Patient 1's allergies and duplication of therapy during order review and prior to making the medications available for patient use, in accordance with hospital policy for one of four patients.
These failures had the potential to increase patients' risk for receiving inappropriate or ineffective medications, medication errors, and medication related adverse effects thereby negatively impacting patients' disease states and overall patients' outcome.
Findings
1. California Code of regulations, Title 22, requires the following, with regards, to emergency medication supplies,
70263 (f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(1) Written policies and procedures establishing the contents of the supply, procedures for use, restocking and sealing of the emergency drug supply shall be developed.
(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.
(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years.
The American Society of Hospital Systems Pharmacists, 1980, Technical Assistance Bulletin on Hospital Drug Distribution and Control, concerning the Emergency Medication Supplies section, indicated the following, "A policy to supply emergency drugs when the pharmacist is off the premises or when there is insufficient time to get to the pharmacy should exist. Emergency drugs should be limited in number to include only those whose prompt use and immediate availability are generally regarded by physicians as essential in the proper treatment of sudden and unforeseen patient emergencies. The emergency drug supply should not be a source for normal "stat" or "p.r.n." drug orders. The medications included should be primarily for the treatment of cardiac arrest, circulatory collapse, allergic reactions, convulsions, and bronchospasm. The P&T committee should specify the drugs and supplies to be included in emergency stocks. Emergency drug supplies should be inspected by pharmacy personnel on a routine basis to determine if contents have become outdated and are maintained at adequate levels. Emergency kits should have a seal which visually indicates when they have been opened. The expiration date of the kit should be clearly indicated."
During medication storage inspection on 8/25/10 at 8:45 a.m., in the emergency department, in the company of the area vice president of quality (Admin 1) and the director of the emergency department (RN 1), the following emergency kits were identified:
? TNKase (tenecteplase ) Box, for use in the reduction of mortality associated with acute myocardial infarction.
? Code Box, used by the emergency room physicians in response to a code (a medical emergency) throughout the hospital.
? RSI Kit (rapid sequence intubation kit), used for the expedient placement of a tube to enable breathing during emergencies.
The TNKase Box contained nitroglycerin (treats chest pain) 0.4 mg, 25 sublingual tablets. Review of the list of contents on the outside of the box did not include nitroglycerin 0.4 mg sublingual tablets. During interview on 8/25/10 at approximately 8:45 a.m., RN 1 stated that nitroglycerin sublingual tablets were necessary to treat patients during an emergency and should be included on the list of medications in the TNKase Box.
The Code Box, used by physicians in response to a code (used to indicate that a patient needs immediate resuscitation usually after a cardiac arrest) on the hospital floors, contained haldol injectable. Haldol injectable may be used for the emergency sedation of severely agitated or delirious patients. During interview on 8/26/10 at 9:50 a.m., the emergency department medical director (MD 1) stated he had not used the injectable haldol in the Code Box during codes. MD 1 said, he was not sure why haldol injectables were part of the Code Box. MD 1 added, the only medication he really needed in response to a code was Rocuronium used to facilitate intubation, which was not always readily available on the floors.
During interview on 8/25/10 at 10:00 a.m., Admin 1 and the Director of Pharmacy (DOP) could not say how the hospital determined the types of emergency boxes or the contents of the emergency boxes available throughout the hospital.
Admin 1 and the DOP provided the following policies regarding emergency kits, approved by the hospital's pharmacy and therapeutics (P&T),
? Procedures for maintaining emergency kits, trays and cart drawer trays, last reviewed on 9/09.
? Crash cart restocking procedure, last reviewed on 5/2010.
Review of both of the policies on 8/26/10 at 7:30 a.m., showed that neither policy included or addressed the contents of the emergency kits found in the emergency room.
The policy titled, "Procedures for maintaining emergency kits, trays and cart drawer trays, indicated the following: "A record of all emergency kits, trays and cart drawer trays and contents thereof will be maintained in the pharmacy. Master forms will be maintained in a readily accessible file, and computerized lists maintained and updated as needed by the pharmacy director."
The DOP provided the following list of emergency kits,
? Emergency department trauma room code tray
? Delivery room neonatal emergency kit
? Labor and delivery adult emergency kit
? TNKase emergency kit
? NICU crash cart meds
According to the DOP, the emergency kits contents had not been approved by the hospital's P&T committee. Additionally, the DOP did not have a list of contents for the RSI kit.
Review of the hospital's,"Crash cart restocking procedure" indicated that a "Crash Cart Check" sticker would be applied to the lower right corner of the tray indicating the date the first drug on the tray would expire and the name of the first drug to expire.
During inspection of the crash cart in the emergency room on 8/25/10 at 9:00 a.m. in the company of Admin 1 and RN 1, the crash carts had stickers indicating the expiration dates of drugs and their location. The stickers did not indicate the name of the expiring drug. RN 1 explained that the expirations on the stickers corresponded to various drawers in the crash cart, such as adult, pediatric or pharmacy supplies such as solutions, but did not specify which drug was expiring.
During medication storage inspection in the operating room hallway on 8/24/10 at 2:30 p.m., in the company of Admin 1, the operating room supervisor nurse (RN 5) and the director of perioperative services (RN 6), a sticker on the crash cart indicated an expiration date. The sticker did not specify the name of the expiring drug.
The MH cart (a cart containing emergency medications and supplies used to treat malignant hyperthermia is a rare life threatening medical emergency, triggered by certain drugs used in anesthesia) had a piece of masking tape with the date of 1/11 written on it, RN 6 said this was probably the date of the earliest expiring drug. RN 5, RN 6 and Admin 1 could not say who placed the masking tape on the MH cart or whether the cart had been sealed by pharmacy.
Review of the hospital's policy and procedures regarding malignant hyperthermia (last reviewed by P&T on 8/10) on 8/26/10 at 7:30 a.m., showed the policy did not indicate who would be responsible for inspecting and sealing the supplies and drugs contained in the MH cart. Additionally, The MH cart was also not included in the provided list of emergency kits maintained by pharmacy, as indicated in the hospital's policy and procedures, entitled, "Procedures for maintaining emergency kits."
Further inspection on 8/24/10 at 2:30 p.m., of the MH cart showed it contained two vials of Heparin 1000 units/ml 20 ml. According to RN 5, the hospital followed MHAUS (Malignant Hyperthermia Association of North America) guidelines for MH. Review of the MHAUS guidelines did not show the use of Heparin during an MH emergency. When asked, RN 5 said she did not know how the heparin would be used during an MH emergency. Admin 1 and RN 6 could not provide an explanation for the presence of Heparin 1000 units/ml, on the list of P&T committee approved contents. RN 6 said that during her eight year employment at the hospital, they have never had an MH emergency. RN 5 said that during an MH emergency, the operating room staff including anesthesiologists would participate. RN 5 and RN 6 stated the hospital had not conducted simulated codes to determine staff competence and readiness to deal with an MH emergency.
2. Fentanyl Patch is a narcotic (opioid) pain medicine applied to the skin. It contains Fentanyl, a very potent narcotic pain medicine. According to the FDA's required boxed warning on the labeling (the strongest warning that the FDA requires), fentanyl patches are only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. Fentanyl patches may cause serious or fatal respiratory depression which could occur when used in patient who are not opiate tolerant.
Due to numerous reports of adverse events with Fentanyl Patches, including fatalities, caused by inappropriate prescribing, dispensing, and administration of the drug, The Food and Drug Administration (FDA) issued a public advisory containing important safety information about using fentanyl transdermal patches, "Deaths and overdoses have occurred, and the directions for the use of this medication must be followed exactly to prevent death or serious side effects."
During interview on 8/24/10 between 10:00 a.m. to 12:00 p.m., in the hospital pharmacy, The DOP stated the hospital had developed a new fentanyl patch policy that had recently been approved by the hospital's P&T (pharmacy and therapeutics) Committee on 7/12/10. The DOP stated fentanyl patches would not be dispensed without a pharmacist evaluating and assessing the order in accordance with the hospital's policy and the FDA's boxed warning. The DOP said the staff pharmacists had been inserviced on the new policy during a staff meeting and those who did not attend the staff meeting, were expected to read the meeting minutes and review the policy. Review of the policy indicated the purpose of the policy was to assure safe and appropriate prescribing of fentanyl patches for all patients.
Contrary to the DOP, in an interview on 8/24/10 at 11:00 a.m., a staff pharmacist (Pharm 2) said the hospital did not have a policy in place regarding the use of fentanyl patches and the actual process for the use of fentanyl patches was being refined. When asked, Pharm 2 could not provide the hospital's policy regarding the use of fentanyl patches or the conversion table used to calculate the fentanyl patch dose.
Record review and interviews on 8/26/10 at 2:00 p.m., in the company of Admin 1, the DOP, Pharm 3 and RN 7, showed the hospital had admitted Patient 3 on 8/23/10. Patient 3 was 88 years old and had come to the hospital emergency department (ED) with complaints that included chest, rib and back pain. The ED diagnosed Patient 3 with bronchitis and pleural effusions (excess fluid that accumulates in the fluid-filled space that surrounds the lungs, which can impair breathing). Patient 3 was started on oxygen to assist with breathing, antibiotics and pain medications.
A hospital document reviewed on 8/26/10, dated 8/23/10 at 11:00 p.m., showed Patient 3's at home medications included fentanyl patch 25 mcg/hr every 72 hours. The form indicated that the patch was last applied on 8/23/10. The form did not include any other pain medications.
A second hospital document reviewed on 8/26/10 also listed Patient 3's at home medications and was dated 8/23/10 at 12:48 p.m. According to this list of medications, Patient 3 was on two fentanyl patches 25 mcg/hr. The form indicated that one patch was applied on 8/21/10 and another patch was applied on 8/23/10. The list did not include any other pain medications.
There was no information in Patient 3's record to indicate how long Resident 3 had used fentanyl patches or the date of the last dose adjustment if any.
Without documented clarification of Patient 3's usual dose of fentanyl patch, the hospital's admission orders included fentanyl patch 75 mcg/hr every 72 hours. Additionally, Patient 3 had orders for Dilaudid (an opioid pain medication used for the management of moderate to severe pain) 0.5 mg IV every 2 hours as needed for breakthrough pain.
The Medication Administration Record indicated that a registered nurse had applied the fentanyl 75 mcg/hr patch to Patient 3's skin on 8/24/10 at 12:35 a.m.
On 8/25/10 at 7:30 a.m., a physician note indicated Patient 3 had an "episode of reduced responsiveness and confusion, more confused than usual". The physician also indicated Patient 3 had received a total of 4.5 mg of IV Dilaudid since admission, in addition to the application of the fentanyl 75 mcg/hr patch. On 8/25/10 at 1:45 p.m., another physician (surgeon) noted that Patient 3 was "not arousable". Patient opens eyes to verbal stimuli but has not meaningful response." On 8/26/10 at 7:25 a.m., another physician noted that Patient 3 had aspirated, stopped breathing for, "4-5 seconds". The note further recorded that after the removal of the fentanyl patch, Patient 3 seemed more alert.
On 8/26/10 at 9:09 a.m., Patient 3's fentanyl 75 mcg/hr patch was changed to 50 mcg/hr.
During the same interview, RN 7 and RN 8 said that Patient 3 had suffered from confusion, severe pain due to pressure sores and back pain. RN 7 said that Patient 3 had an episode of altered mental status and was difficult to arouse on 8/24/10 at approximately 7:00 p.m.; and subsequently, the "as needed" pain medications were changed and the fentanyl patch dose was reduced.
The fentanyl patch manufacturer's package insert reviewed on 8/26/10 indicated that adverse events related to fentanyl patches included somnolence and confusion (occur in 10% or more of patients). Additionally, the concomitant use of fentanyl patches with other opioids may cause respiratory depression, hypotension and profound sedation or potentially result in coma or death. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Furthermore, elderly and debilitated patients may have increased sensitivity to the fentanyl patch due to poor fat stores, muscle wasting, or reduction in the ability to remove the drug from the body. Respiratory depression is the chief hazard in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Additionally, serious or life-threatening hypoventilation may occur at any time during the use the fentanyl patch, especially during the initial 24-72 hours following initiation of therapy and following increases in dose.
Based on Patient 3's age, medical condition and respiratory status, the fentanyl patch dose increase to 75 mcg/hour, upon admission, in combination with the administration IV Dilaudid, exposed Patient 3 to serious or life threatening consequences.
On 8/26/10, DOP and Pharm 3 could not provide any documentation of the pharmacist's interventions or assessment of the appropriateness of the fentanyl patch dose for Patient 3. Pharm 3 indicated that the pharmacist who reviewed and approved the order had noted that the patient had been on a fentanyl patch prior to admission. Pharm 3 stated she would have assessed the appropriateness of increasing Patient 3's fentanyl patch to 75 mcg/hr based on usage of as needed medications and Patient 3's pain. Pharm 3 said she would not have approved the fentanyl patch dose increase without evaluating and assessing Patient 3's pain and history of use of as needed pain medications. Pharm 3 said she attempted to contact the physician to clarify the order but could not reach him. DOP stated that pharmacists are expected to document their interventions regarding fentanyl patch use, especially when physicians are contacted.
The manufacturer package insert, regarding increasing fentanyl patch doses, indicated the following:
"The initial fentanyl patch dose may be increased after 3 days based on the daily
dose of supplemental opioid analgesics required by the patient in the second or third day of the initial application. Additionally, it may take up to 6 days after increasing the dose for the patient to reach equilibrium on the new dose, therefore patients should wear a higher dose through two applications before any further increase in dosage is made on the basis of the average daily use of supplemental analgesics. Appropriate dosage increments should be based on the daily dose of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12.5 mcg/h increase in fentanyl patch dose."
The hospital staff did not clarify Patient 3's fentanyl patch dose prior to admission, 25 mcg/hr or 50 mcg/hr. Additionally, if Patient 3's dose was increased to 50 mcg/hr fentanyl patch dose prior to admission, the hospital did not obtain the date of the dose increase. Furthermore, according to the medication reconciliation forms, Patient 3 was not using any supplemental opioid analgesics to justify the fentanyl patch dose increase to 75 mcg/hr.
The hospital's recently approved policy and procedures, 'The Criteria for Safe and Appropriate Prescribing of Fentanyl Transdermal Patches' (62-3317/adopted 7/12/10) did not address fentanyl patch dose titration. Additionally, the policy did not require documentation of the pharmacist's interventions or analysis of the appropriateness of the fentanyl patch dose.
ISMP's Fentanyl Patch safe practice recommendations include the following:
"Creating specific prescribing and dispensing guidelines"
"Determining the indication: Pharmacists should determine the indication and ensure that the patient is opiate-tolerant and suffering from chronic pain before dispensing the medication.. Verification of the indication and any conversations with the prescriber regarding the patient and the prescribed medication should be documented in a consistent place."
3. Patient 2's record review was conducted on 8/26/10 at 4:30 p.m., in the company of Admin 1, the Director Of Pharmacy, and the medical oncology charge nurse (RN 7) and the unit supervisor (RN 8) showed that the hospital had admitted Patient 2 on 8/8/10 for respiratory failure and altered mental status after a fall. Patient 2's medical history included chronic obstructive pulmonary disease and diabetes.
Patient 2 had physicians orders dated 8/9/10 at 4:20 a.m. for Insulin Sensitive Sliding Scale (a sensitive scale is less aggressive dosing than a regular sliding scale insulin) Novolog Insulin (Novolog is a type of insulin). On 8/11/10 at 10:59 a.m., the physician changed the orders to Sliding Scale Insulin Regular. On 8/11/10 at 7:26 p.m., a nurse clarified the orders with the physician via telephone as follows, Finger Stick Blood Sugars, before meals and at bedtime, Regular Insulin Sliding Scale with Novolog Insulin. The physician signed the orders on 8/12/10 at 1:05 p.m.
Review of Patient 2's blood sugars and insulin administration record showed the following:
8/25/10 4:30 p.m.: blood sugar 162, Patient 2 received 2 units of Novolog insulin. According to the regular sliding scale insulin order form, Patient 2 should have received 3 units of insulin.
Further review of Patient 2's medical record and interview with the DOP on 8/26/10 at 5:15 p.m., showed the pharmacist who had approved the order on 8/11/10 had entered the Sensitive Sliding Scale Novolog Insulin rather than Regular Sliding Scale Novolog Insulin. The pharmacy order entry drives the medication administration record (MAR). According to RN 7 and RN 8, the nurses uses the MAR to determine the required dose of insulin.
Further review of Patient 2's medical record showed Patient 2 had orders for Advair inhaler (a corticosteroid containing inhaler). Advair is used for the maintenance treatment of chronic obstructive pulmonary disease. The original order date was 8/11/10 for 1 puff twice daily. Record review on 8/26/10 at approximately 12:30 p.m. with RN 7 and DOP showed the Advair inhaler had stopped showing on the MAR as of 8/21/10 evening dose. Patient 2's record did not include any orders to discontinue Advair. DOP and the medical oncology unit pharmacist, Pharm 3 said the order had dropped off the MAR due to the hospital's automatic stop order process. The DOP stated the hospital's stop order policy applied to pain medications, antibiotics and corticosteroids. Patient 2's medical record contained a medication renewal list with a run date of 8/17/10. The medication renewal list indicated the stop date for the Advair would be 8/18/10, and directed the physician, "to check all orders you want continued and sign below." The form showed that a telephone order was obtained from the physician on 8/24/10 to continue the Advair.
Review on 8/26/10 at 5:30 p.m., of the hospital's "Drug Stop-Order Policy" (62-2701/revised 9/09), indicated the following:
High risk and problem prone medications prescribed for patients will be reviewed every
seven days. All medications prescribed for patients will be reviewed every 30 days. Pharmacy would provide physicians with a form containing medications that required physicians' decision to continue or discontinue with physician signature, two days prior to the discontinuation date. Any forms that remain unsigned will be returned to pharmacy. Pharmacy will then contact the physicians who have not completed the form. No drug will be discontinued until an order to do so is received from the physician.
Patient 2 did not receive five doses of inhalation Advair, starting 8/21/10 evening dose through the 8/23/10 evening dose. Pharm 3 and RN 7 said that this was a medication error because the physician did not renew the orders on time.
4. Patient 1's Record review on 8/26/10 at 9:50 a.m. in the company of the Admin 1, a CCU staff nurse (RN 2), the CCU manager (RN 4), and the Director Of Pharmacy (DOP), showed the hospital had admitted Patient 1 on 8/25/10 for complaints of chest pain and to rule out a myocardial infarction. Patient 1 had no significant past medical history. Patient 1's medical record indicated the following "No allergy information, please call". The DOP said the process for entering allergies into patient's record was for the nurses to gather and enter the allergy information into the computer system and then for pharmacy to verify the allergy information. When asked about how the pharmacist reviewed, verified and dispensed Patient 1's medication orders without allergy information, the DOP said the pharmacist should have verified and entered the allergy information prior to reviewing orders and dispensing medications.
Review of the hospital policy and procedures titled, 'Prescribing, Ordering and Transcribing Medication Orders' (62-203/adopted on 8/3/10) indicated the pharmacist upon receipt of the order would verify the patient's allergy information had been entered into the pharmacy database. Additionally the pharmacist will review the medication profile and new medication orders for duplication of therapy, allergies, appropriateness, strength/dose, frequency, route and indications.
Further review of Patient 1's Medication Administration Record (MAR) and physicians orders showed the following active orders for morphine (pain medication):
Morphine 2 mg intravenously every two hours as needed for chest pain, entered on 8/25/10 at 9:30 p.m. This entry was based on physicians orders, dated 8/25/10 at 9:00 p.m. for morphine sulfate 2 mg intravenously every two hours as needed for chest pain.
Morphine 2 mg intravenously every 5 minutes as needed for moderate pain, entered on 8/25/10 at 11:15 p.m. and Morphine 4 mg intravenously every 5 minutes as needed for severe chest pain, entered on 8/25/10 at 11:11 p.m.
The two entries above were based on the Myocardial Infarction order set, dated 8/25/10 at 9:25 p.m. for morphine sulfate 2 mg intravenously every 5 minutes as needed for mild chest pain intravenously every 5 minutes as needed for severe chest pain.
During the same interview, the DOP said the new morphine orders superseded the first order, which should have been discontinued to avoid duplication of orders and inconsistent administration of pain medications.